KETOROLAC TROMETHAMINE

N/A

Manufactured by Allergan, Inc.

10,197 FDA adverse event reports analyzed

Last updated: 2026-04-15

About KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. The most commonly reported adverse reactions for KETOROLAC TROMETHAMINE include DRUG INEFFECTIVE, DRUG HYPERSENSITIVITY, NAUSEA, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for KETOROLAC TROMETHAMINE.

Top Adverse Reactions

DRUG INEFFECTIVE559 reports
DRUG HYPERSENSITIVITY322 reports
NAUSEA281 reports
HEADACHE272 reports
PAIN269 reports
FATIGUE245 reports
DYSPNOEA238 reports
OFF LABEL USE229 reports
TREATMENT FAILURE213 reports
EYE PAIN204 reports
VOMITING176 reports
EYE IRRITATION171 reports
DIZZINESS159 reports
DIARRHOEA158 reports
VISION BLURRED143 reports
PRODUCT DOSE OMISSION ISSUE133 reports
ANXIETY132 reports
BACK PAIN132 reports
FALL129 reports
PNEUMONIA127 reports
RASH127 reports
CHEST PAIN126 reports
PRURITUS124 reports
ARTHRALGIA122 reports
MIGRAINE115 reports
PYREXIA115 reports
ABDOMINAL PAIN113 reports
CATARACT113 reports
PAIN IN EXTREMITY113 reports
ASTHENIA109 reports
COUGH101 reports
NASAL DISCOMFORT98 reports
HYPOTENSION97 reports
MALAISE95 reports
SINUSITIS93 reports
HYPERTENSION92 reports
ABDOMINAL PAIN UPPER89 reports
DEPRESSION89 reports
ACUTE KIDNEY INJURY87 reports
URINARY TRACT INFECTION87 reports
DRUG INTERACTION86 reports
URTICARIA86 reports
BRONCHITIS85 reports
WEIGHT DECREASED85 reports
DEATH82 reports
ERYTHEMA80 reports
ANAEMIA79 reports
ASTHMA78 reports
FEELING ABNORMAL76 reports
HYPOAESTHESIA76 reports
OCULAR HYPERAEMIA74 reports
VISUAL IMPAIRMENT74 reports
INSOMNIA73 reports
INJECTION SITE PAIN72 reports
GAIT DISTURBANCE70 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS69 reports
COVID 1968 reports
RENAL FAILURE68 reports
ULCERATIVE KERATITIS68 reports
ANAPHYLACTIC REACTION67 reports
PRODUCT QUALITY ISSUE67 reports
PRODUCT USE IN UNAPPROVED INDICATION66 reports
PRODUCT USE ISSUE66 reports
BLOOD PRESSURE INCREASED65 reports
CONDITION AGGRAVATED65 reports
HYPERSENSITIVITY65 reports
CONSTIPATION64 reports
MUSCLE SPASMS64 reports
OEDEMA PERIPHERAL64 reports
SOMNOLENCE64 reports
VISUAL ACUITY REDUCED64 reports
LOSS OF CONSCIOUSNESS63 reports
DECREASED APPETITE62 reports
DRUG INTOLERANCE62 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION62 reports
CARDIAC DISORDER60 reports
CONTUSION58 reports
MYALGIA57 reports
PARAESTHESIA57 reports
RENAL FAILURE ACUTE57 reports
INFECTION56 reports
PERIPHERAL SWELLING56 reports
BURNING SENSATION55 reports
INJURY55 reports
WEIGHT INCREASED55 reports
ABDOMINAL DISTENSION53 reports
GASTROINTESTINAL HAEMORRHAGE53 reports
LACRIMATION INCREASED53 reports
CHRONIC KIDNEY DISEASE52 reports
INCORRECT DOSE ADMINISTERED51 reports
CHEST DISCOMFORT50 reports
HYPERHIDROSIS50 reports
NEPHROLITHIASIS50 reports
SNEEZING50 reports
TACHYCARDIA50 reports
DIABETES MELLITUS49 reports
EMOTIONAL DISTRESS49 reports
PULMONARY EMBOLISM49 reports
ABDOMINAL DISCOMFORT48 reports
ANGIOEDEMA48 reports

Report Outcomes

Out of 5,420 classified reports for KETOROLAC TROMETHAMINE:

Serious 55.8%Non-Serious 44.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,933 (64.6%)
Male1,598 (35.2%)
Unknown10 (0.2%)

Reports by Age

Age 6376 reports
Age 7472 reports
Age 6063 reports
Age 6163 reports
Age 6561 reports
Age 6961 reports
Age 7061 reports
Age 7361 reports
Age 4960 reports
Age 5060 reports
Age 5460 reports
Age 7560 reports
Age 4656 reports
Age 6856 reports
Age 5855 reports
Age 5554 reports
Age 5954 reports
Age 5153 reports
Age 6652 reports
Age 7850 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with KETOROLAC TROMETHAMINE?

This profile reflects 10,197 FDA FAERS reports that mention KETOROLAC TROMETHAMINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETOROLAC TROMETHAMINE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG HYPERSENSITIVITY, NAUSEA, HEADACHE, PAIN, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures KETOROLAC TROMETHAMINE?

Labeling and FAERS entries often list Allergan, Inc. in connection with KETOROLAC TROMETHAMINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.